PLENARY ONE – Monday, June 17, 2019

HTA Beyond 2020: One Size Fits All? Will Joint International Assessments Improve Or Hinder HTA?

HTA faces a dilemma: on one hand, it stresses the availability and usage of methodologically sound studies (and has thus invested a fair amount of energy to evaluate and classify both the quality of data sources as well as the methodology to evaluate data and report results); on the other hand, it stresses the applicability of data and results to the national / regional / local context.

The first perspective – the consensus that study methodology and HTA evaluation standards apply independent of context – has led to relative homogeneity in how HTA institutions evaluate evidence. In principle, there is agreement on (1) the necessity of high-quality studies providing data on “comparative effectiveness” (or “additional benefit”) as compared to current practice (instead of only having data on efficacy), (2) expanding the methodology to technologies other than pharmaceuticals (especially medical devices), and (3) context-dependent evidence requirements on ethical, organizational/professional, social, legal, and economic implications.

The second aspect of the dilemma is that, as many decision-makers, and HTA institutions themselves, stress the context-dependency of HTA-based decisions, the availability of high-quality “real world” studies is hindered by the fact that requirements (e.g., regarding subgroups or comparators) are defined differently in every decision-making context.

Proponents of a new phase of international collaboration argue that undertaking and using joint cross-country assessments will (1) be based on joint methodologies and requirements, and that this will increase the availability of high-quality “real world” data (such as drug licencing requirements have improved the quality of clinical trials), and (2) increase the availability of HTA reports, especially in smaller countries which cannot support their own HTA infrastructure. Opponents, however, fear that the context-specificity (and thus usefulness to the national / regional / local setting) will get lost if assessments will be done on a higher level.

Based on these conflicting models of HTA, the session will consist of:

1 – a short overview of international collaboration in HTA methodology and assessments;

2 – arguments in favour of undertaking and using joint assessments within the EU;

3 – arguments against undertaking and using joint assessments within the EU; and

4 – a view from the outside: what can countries around the word learn from the European experience and debate?

Moderator: Reinhard Busse, Technical University Berlin, Germany


Martin Seychell, DG Health and Food Safety, Malta
Dr. Michelle Mujoomdar, Canadian Agency for Drugs and Technologies in Health (CADTH), Canada
Martin Czech, Deputy Minister, Poland
Dr. Federico Augustovski, Institute for Clinical Effectiveness and Health Policy (IECS), Argentina



PLENARY TWO – Tuesday, June 18, 2019

HTA Beyond 2020: The Era Of Digital Health?

Digitalization is expected to lead to major changes in healthcare and research in the years to come. It is clear that these changes will have an impact on HTA beyond 2020. Even now, various HTA experts think that digital health presents enormous challenges as well as opportunities.

First, digitalization leads to new treatment options. Some digital health applications only replace their non-digital counterparts; other applications, however, aim to increase the effectiveness and efficiency of medical care. This includes smart medical devices, mobile apps, telehealth, virtual reality surgery, artificial intelligence (AI) diagnostics, and digital therapeutics (“digiceuticals”). However, digitalization in healthcare could also improve access to services, socio-economic inclusion, equality, patient empowerment, and shared decision-making. After highlighting a few highly innovative examples, the session will explore different views on how much and which type of evidence is needed for new digital health interventions.

Second, digitalization allows researchers to collect a wide array of data in new ways. Not all data can be called “big data”, as they lack volume, velocity, variety, veracity, or (most importantly) value, not to mention the concerns related to the epistemological, methodological, applicative, and social aspects. Digital health data nevertheless show great potential for use in clinical research and HTA. Social media data, for example, can be used to evaluate the safety and acceptability of health interventions. Patient-reported outcomes or functional data can be elicited on a daily basis through mobile apps. Automatic data extraction could speed up the use of clinical research reports in HTA. Harnessing all of the data, however, requires extensive efforts for data extraction, cleansing, transformation, and analysis.

This session will show where and how HTA might be improved by using digital data and tools but will also offer insight into some potential hurdles and traps.

Moderator:  Professor Jeonghoon Ahn, Ewha Womans University, Korea

Dr. Anne G. Ekeland, Norwegian Centre for E-health Research, Norway
Dr. Ain Aaviksoo, Guardtime Health, Estonia
Professor Rainer Röhrig, Germany


PLENARY THREE – Wednesday, June 19, 2019

HTA Beyond 2020: Need For Smart Capability Building?

The changing face of biomedical and healthcare service innovation, the increased availability of data and evidence to assess and optimize the impact of healthcare interventions and technology, as well as evolving expectations of stakeholders represent considerable opportunities and challenges for HTA to maintain and strengthen its relevance. What will be the role of HTA beyond 2020? Will new HTA capabilities be required? And if so, how can we be smart in building new HTA capabilities?

Capabilities mean not only the methodological and practical skills of individuals that perform HTA but also the overall institutional capabilities of organizations involved in HTA (e.g., processes, knowledge management, governance, technical infrastructure) that may be required to successfully contribute to effectiveness and affordability of healthcare systems. For example:

Building new HTA capabilities represents a challenge to already resource constrained healthcare systems and organizations active in the field of HTA. The only option is to be smart in how these additional HTA capabilities are built and made accessible. But what does this mean?

The third plenary session complements the other plenary sessions with a focus on how to best establish new HTA capabilities that will be required post 2020. In light of anticipated future healthcare system trends, panel participants representing stakeholder groups actively participating in HTA (HTA agency, patient groups, industry) will:


Moderator:  Dr. Brian O’Rourke, Canadian Agency for Drugs and Technologies in Health (CADTH), Canada
Dr. Siw Waffenschmidt, Institute for Quality and Efficiency in Health Care (IQWiG), Germany
Professor Kanchan Mukherjee, Tata Institute of Social Sciences (TISS), India
Dr. Bettina Ryll, Founder, Melanoma Patient Network Europe, Sweden
Mrs. Gesa Pellier, Novartis Pharma AG, Switzerland